Table 3. Summary of Safety Results through Week 8 (Combined UNITI-1 and-2 Study).
| Description | Placebo | Ustekinumab 130 mg | Ustekinumab ~6 mg/kg | Combined | ||||
|---|---|---|---|---|---|---|---|---|
| Japan (n=27) | All (n=466) | Japan (n=28) | All (n=471) | Japan (n=28) | All (n=470) | Japan (n=55) | All (n=941) | |
| Average duration of follow-up (wk) | 7.80 | 8.18 | 7.93 | 8.22 | 8.10 | 8.16 | 8.02 | 8.19 |
| TEAE | 15 (55.6) | 282 (60.5) | 12 (44.4) | 275 (58.4) | 14 (50.0) | 284 (60.4) | 26 (47.3) | 559 (59.4) |
| Serious TEAE | 2 (7.4) | 28 (6.0) | 0 | 23 (4.9) | 2 (7.1) | 25 (5.3) | 2 (3.6) | 48 (5.1) |
| Infectiona | 6 (22.2) | 108 (23.2) | 5 (18.5) | 92 (19.5) | 7 (25.0) | 111 (23.6) | 12 (21.8) | 203 (21.6) |
| Serious infectiona | 0 | 6 (1.3) | 0 | 7 (1.5) | 0 | 8 (1.7) | 0 | 15 (1.6) |
| TEAEs leading to discontinuation of study drug | 1 (3.7) | 19 (4.1) | 0 | 8 (1.7) | 0 | 8 (1.7) | 0 | 16 (1.7) |
Values are presented as number (%).
aInfection as assessed by the investigator.
TEAE, treatment-emergent adverse event.